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Bevacizumab and Sunitinib in Treating Patients With Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00357318
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in treating patients with solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: bevacizumab
Drug: sunitinib malate
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate Bevacizumab Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Bevacizumab in Combination With SU11248

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose bevacizumab and sunitinib malate (SU11248) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective tumor response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2006
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of bevacizumab in combination with sunitinib malate (SU11248) in patients with solid tumors.

Secondary

  • Evaluate the objective response rate, time to disease progression, and overall survival of these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bevacizumab and SU11248 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.

After completion of study therapy, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven malignant solid tumor not amenable to curative surgical therapy or radiation therapy
  • No squamous cell histology
  • No histology in close proximity to a major blood vessel
  • No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis
  • No new evidence of brain or leptomeningeal disease on screening CT scan or MRI

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • Calcium ≤ 12.0 mg/dL
  • Urine protein:creatinine ratio ≤ 0.5 by urinalysis

    • Patients with urine protein:creatinine ratio > 0.5 must have proteinuria < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
  • None of the following within the past 12 months:

    • Myocardial infarction
    • Severe/unstable angina
    • Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature
    • Coronary/peripheral artery bypass graft
    • New York Heart Association (NYHA) grade III-IV congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Clinically significant bleeding
    • Deep venous thrombosis
    • Pulmonary embolism
  • No ongoing cardiac dysrhythmias of NCI CTCAE ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females)
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No condition classified as NYHA grade III or IV
  • No hypertension that cannot be controlled by medications

    • Blood pressure < 140/90 mm Hg
  • No evidence of bleeding diathesis or coagulopathy
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No serious, non-healing wound, ulcer, or bone fracture
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known HIV or AIDS-related illness
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • Recovered from prior radiation therapy, surgery, or other prior therapy
  • No prior bevacizumab or sunitinib malate (SU11248)

    • Other antiangiogenic therapies allowed
  • No prior tyrosine kinase inhibitor of the VEGF receptor or bevacizumab for patients with metastatic renal cell carcinoma
  • No major surgical procedures or open biopsy within the past 28 days
  • No core biopsy within the past 7 days
  • No radiation therapy or systemic therapy within the past 4 weeks
  • No concurrent full-dose anticoagulants (e.g., warfarin)

    • Concurrent low-dose anticoagulation (e.g., prophylactic port patency) allowed
  • No concurrent treatment on another clinical trial
  • No other concurrent investigational drugs
  • No concurrent major surgery
  • No other concurrent anticancer agents or therapies, including chemotherapy, biological response modifiers, hormonal therapy, surgery, palliative radiation therapy, or immunotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357318

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Geauga Regional Hospital Recruiting
Cleveland, Ohio, United States, 44024
Contact: Matthew M Cooney     216-691-0100        
Lake/University Ireland Cancer Center Recruiting
Cleveland, Ohio, United States, 44060
Contact: Matthew M Cooney     216-691-0100        
University Suburban Health Center Recruiting
Cleveland, Ohio, United States, 44121
Contact: Matthew M Cooney     216-691-0100        
Southwest General Health Center Recruiting
Cleveland, Ohio, United States, 44130
Contact: Matthew M Cooney     216-691-0100        
UHHS Chagrin Highlands Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Matthew M Cooney     216-691-0100        
UHHS Westlake Medical Center Recruiting
Cleveland, Ohio, United States, 44145
Contact: Matthew M Cooney     216-691-0100        
Mercy Cancer Center at Mercy Medical Center Recruiting
Cleveland, Ohio, United States, 44708
Contact: Matthew M Cooney     216-691-0100        
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Brian I. Rini, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000489184, CASE-5Y05, CASE-5Y05-CC008, NCI-7537
Study First Received: July 26, 2006
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00357318  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Sunitinib
Bevacizumab

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009